Toujeo Solostar is a drug owned by Sanofi Us Services Inc. It is protected by 21 US drug patents filed from 2015 to 2019. Out of these, 5 drug patents are active and 16 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 16, 2035. Details of Toujeo Solostar's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10369291 | Mechanism for a drug delivery device |
Sep, 2035
(10 years from now) | Active |
| US9345750 | Long-acting formulations of insulin |
May, 2031
(6 years from now) | Active |
|
US7918833 (Pediatric) | Pen-type injector |
Mar, 2028
(3 years from now) | Active |
| US7918833 | Pen-type injector |
Sep, 2027
(2 years from now) | Active |
| US8679069 | Pen-type injector |
Apr, 2025
(3 months from now) | Active |
| US8512297 | Pen-type injector |
Sep, 2024
(3 months ago) |
Expired
|
| US9561331 | Drive mechanisms suitable for use in drug delivery devices |
Aug, 2024
(3 months ago) |
Expired
|
| US9623189 | Relating to drive mechanisms suitable for use in drug delivery devices |
Aug, 2024
(3 months ago) |
Expired
|
| US9533105 | Drive mechanisms suitable for use in drug delivery devices |
Aug, 2024
(4 months ago) |
Expired
|
| US9604009 | Drive mechanisms suitable for use in drug delivery devices |
Aug, 2024
(4 months ago) |
Expired
|
| US8992486 | Pen-type injector |
Jun, 2024
(6 months ago) |
Expired
|
| US9011391 | Pen-type injector |
Mar, 2024
(8 months ago) |
Expired
|
| US8556864 | Drive mechanisms suitable for use in drug delivery devices |
Mar, 2024
(9 months ago) |
Expired
|
| US9233211 | Relating to a pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US9408979 | Pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US9604008 | Drive mechanisms suitable for use in drug delivery devices |
Mar, 2024
(9 months ago) |
Expired
|
| US9775954 | Pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US8603044 | Pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US9827379 | Drive mechanisms suitable for use in drug delivery devices |
Mar, 2024
(9 months ago) |
Expired
|
| US9526844 | Pen-type injector |
Mar, 2024
(9 months ago) |
Expired
|
| US9610409 | Drive mechanisms suitable for use in drug delivery devices |
Mar, 2024
(9 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Toujeo Solostar's patents.
Latest Legal Activities on Toujeo Solostar's Patents
Given below is the list of recent legal activities going on the following patents of Toujeo Solostar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Nov, 2023 | US9345750 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jan, 2023 | US10369291 |
| Post Issue Communication - Certificate of Correction | 13 Nov, 2019 | US10369291 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Nov, 2019 | US9345750 |
| Recordation of Patent Grant Mailed Critical | 06 Aug, 2019 | US10369291 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Aug, 2019 | US10369291 |
| Email Notification Critical | 18 Jul, 2019 | US10369291 |
| Issue Notification Mailed Critical | 17 Jul, 2019 | US10369291 |
| Dispatch to FDC | 26 Jun, 2019 | US10369291 |
| Application Is Considered Ready for Issue Critical | 20 Jun, 2019 | US10369291 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Toujeo Solostar and ongoing litigations to help you estimate the early arrival of Toujeo Solostar generic.
Toujeo Solostar's Litigations
Toujeo Solostar been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 10, 2018, against patent number US8992486. The petitioner Mylan Pharmaceuticals Inc et al., challenged the validity of this patent, with Sanofi-Aventis Deutschland GmbH et al. as the respondent. Click below to track the latest information on how companies are challenging Toujeo Solostar's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8679069 | May, 2019 |
FWD Entered
(11 Aug, 2020) | Sanofi-Aventis Deutschland | Pfizer Inc. |
| US8603044 | September, 2018 |
FWD Entered
(29 May, 2020) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc. |
| US8992486 | September, 2018 |
FWD Entered
(29 May, 2020) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc. |
| US8992486 | October, 2018 |
FWD Entered
(29 May, 2020) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc. |
| US9526844 | September, 2018 |
FWD Entered
(29 May, 2020) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc |
| US9526844 | September, 2018 |
FWD Entered
(29 May, 2020) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc. |
| US9604008 | September, 2018 |
FWD Entered
(29 May, 2020) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc. |
| US8679069 | September, 2018 |
FWD Entered
(02 Apr, 2020) | Sanofi-Aventis Deutshland GmbH | Mylan Pharmaceuticals Inc. |
| US9526844 | May, 2019 |
Terminated-Other
(20 Aug, 2019) | Sanofi-Aventis Deutschland | Pfizer Inc. |
| US9526844 | May, 2019 |
Terminated-Other
(19 Aug, 2019) | Sanofi-Aventis Deutschland | Pfizer Inc. |
| US8603044 | May, 2019 |
Terminated-Other
(15 Aug, 2019) | Sanofi-Aventis Deutschland | Pfizer Inc. |
| US8992486 | May, 2019 |
Terminated-Other
(15 Aug, 2019) | Sanofi-Aventis Deutschland | Pfizer Inc. |
| US9604008 | May, 2019 |
Terminated-Other
(15 Aug, 2019) | Sanofi-Aventis Deutschland | Pfizer Inc. |
| US9526844 | September, 2018 |
Terminated-Denied
(03 Apr, 2019) | Sanofi-Aventis Deutschland GmbH | Mylan Pharmaceuticals Inc. |
| US8992486 | September, 2018 |
Terminated
(19 Dec, 2018) | Sanofi-Aventis Deutschland GmbH et al. | Mylan Pharmaceuticals Inc et al. |
FDA has granted some exclusivities to Toujeo Solostar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Toujeo Solostar, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Toujeo Solostar.
Exclusivity Information
Toujeo Solostar holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Toujeo Solostar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 25, 2018 |
| New Patient Population(NPP) | Nov 26, 2022 |
US patents provide insights into the exclusivity only within the United States, but Toujeo Solostar is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Toujeo Solostar's family patents as well as insights into ongoing legal events on those patents.
Toujeo Solostar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Toujeo Solostar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Toujeo Solostar Generics:
There are no approved generic versions for Toujeo Solostar as of now.
Alternative Brands for Toujeo Solostar
Toujeo Solostar which is used for managing glycemic control in diabetes mellitus patients., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Glargine Recombinant). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Sanofi Aventis Us |
| |||||
| Sanofi-aventis Us |
| |||||
| Sanofi Us Services |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Insulin Glargine Recombinant. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Sanofi Aventis Us |
|
About Toujeo Solostar
Toujeo Solostar is a drug owned by Sanofi Us Services Inc. It is used for managing glycemic control in diabetes mellitus patients. Toujeo Solostar uses Insulin Glargine Recombinant as an active ingredient. Toujeo Solostar was launched by Sanofi Us Services in 2015.
Approval Date:
Toujeo Solostar was approved by FDA for market use on 25 February, 2015.
Active Ingredient:
Toujeo Solostar uses Insulin Glargine Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Glargine Recombinant ingredient
Treatment:
Toujeo Solostar is used for managing glycemic control in diabetes mellitus patients.
Dosage:
Toujeo Solostar is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 450 UNITS/1.5ML (300 UNITS/ML) | SOLUTION | Prescription | SUBCUTANEOUS |